NCT01941914已完成1 期
Calcium Electroporation for the Treatment of Keloids
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Response evaluated by Vancouver Scar Scale
研究概览
简要总结
The purpose of this study is to evaluate the effect of calcium electroporation on keloids.
详细描述
The keloids wil be treated with intratumoral injection of calcium followed by electroporation. It is a once only treatment and the patients will be followed up for 24 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 1 keloid available to electroporation.
- •Patient should have been offered standard treatment.
- •At least 8 weeks since other keloid treatment.
- •Performance status <2 (ECOG).
- •Platelet count >50 mia/l
- •International Normalized Ratio (INR) <1,
- •Patient should be able to understand participants information.
- •Signed, informed consent.
排除标准
- •Clinically significant coagulopathy.
- •Pregnancy or lactation.
- •Participation in other clinical trial involving experimental drugs or participation in a clinical trial within 4 weeks before study treatment.
研究组 & 干预措施
Calcium electroporation
Experimental
The keloid will be treated with intratumoral injection of calcium chloride followed by electrotransfer. It is a once only treatment.
Calcium chlorid concentration is 9 mg/ml Total dose is 0,5ml/cm3 tumor volume.
干预措施: Calcium chloride (Drug)
结局指标
主要结局
Response evaluated by Vancouver Scar Scale
时间窗: After 6 months
Vancouver scar scale evaluate the keloids by: pigmentation, pliability, height, and vascularity.
次要结局
- Adverse events to calcium electroporation.(After 6 months.)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
Calcium Electroporation for Treatment of Cutaneous MetastasesCutaneous MetastasesNCT01941901Herlev Hospital7
进行中（未招募）
2 期
Calcium Electroporation as a Treatment for Cutaneous and Subcutaneous Malignant TumoursCancerNCT04225767Zealand University Hospital19
进行中（未招募）
1 期
Calcium electroporation for the treatment of cutaneous metastases.EUCTR2012-005704-17-DKJulie Gehl15
招募中
1 期
Effects of calcium electroporation, electrochemotherapy, and irreversible electroporation (IRE-CaCl2, ECT and IRE) on quality of life and progression – free survival in patients with pancreatic cancer (IREC).CTIS2024-512487-61-00Wroclaw Medical University73
招募中
1 期
Effects of calcium electroporation, electrochemotherapy, and irreversible electroporation of life and progression in patients with pancreatic cancer.nresectable pancreatic cancerMedDRA version: 21.0Level: LLTClassification code 10033606Term: Pancreatic cancer non-resectableSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2021-004987-91-PLniwersytet Medyczny im. Piastów Slaskich we Wroclawiu73